Evidence map›Paper›PMID 35286164›Full record

ReviewCirculation2022

Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium.

David E Kandzari, Felix Mahfoud, Michael A Weber, Raymond Townsend, Gianfranco Parati, Naomi D L Fisher, Melvin D Lobo, Michael Bloch, Michael Böhm, Andrew S P Sharp and 21 more

2 registry-linked trialsOpen access · hybridAbstract readReviewConsensus Statement
In one paragraph

Review in Circulation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 41 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 5 pooled it
11.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06141200 phase3unknown statusnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of Roselle in Patients With Grade 1 Essential Hypertension: A Phase III, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial

TypeinterventionalSponsorNatural Wellness EgyptRan2024 to 2025Enrolled286ConditionsEssential HypertensionArmsNW Roselle, Captopril 25Mg Tab
NCT07074145 narecruitingnot on this mapstarted 2025, after this paper: background citation

WEAVE NM Project: Heart Health and Nutrition for Life (HHNL)

TypeinterventionalSponsorUniversity of New MexicoRan2025 to 2027Enrolled240ConditionsHypertensionArmsHeart Health and Nutrition for Life (HHNL), Self-Measured Blood Pressure
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 5 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  4. Guideline
  5. Pooled it
  6. Trial
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  20. Renal denervation for hypertension.Nature reviews. Cardiology · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 10 countries.

David E KandzariPiedmont Heart Institute, Atlanta, GA (D.E.K.).ORCID 0000-0002-0868-6655
Felix MahfoudPiedmont Heart Institute, Atlanta, GA (D.E.K.).ORCID 0000-0002-4425-549X
Michael A WeberState University of New York, Downstate Medical College, New York (M.A.W.).ORCID 0000-0002-8504-0831
Raymond TownsendUniversity of Pennsylvania, Perelman School of Medicine, Philadelphia (R.T.).ORCID 0000-0002-3215-9118
Gianfranco ParatiDepartment of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy (G.P.).ORCID 0000-0001-9402-7439
Naomi D L FisherBrigham and Women's Hospital, Boston, MA (N.D.L.F.).ORCID 0000-0003-1649-1441
Melvin D LoboBarts National Institute for Health Research Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, United Kingdom (M.D.L.).ORCID 0000-0002-1122-948X
Michael BlochUniversity of Nevada/Reno School of Medicine (M. Bloch).
Michael BöhmKlinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany (F.M., M. Böhm, C.U.).ORCID 0000-0002-2976-2514
Andrew S P SharpUniversity Hospital of Wales, Cardiff and University of Exeter, United Kingdom (A.S.P.S.).
Roland E SchmiederDepartment of Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University Erlangen/Nürnberg, Germany (R.E.S.).ORCID 0000-0003-2356-5883
Michel AziziUniversity of Paris, Institut national de la santé et de la recherche médicale (INSERM), Centre d'investigation clinique 418, Assistance Publique-Hôpitaux de Paris Hypertension Department and Département médico-universitaire Cardiologie Rein Transplantation Neurovasculaire, Georges Pompidou European Hospital, France (M.A.).
Markus P SchlaichDobney Hypertension Centre, School of Medicine-Royal Perth Hospital Unit and Research Foundation, University of Western Australia (M.P.S.).ORCID 0000-0002-1765-0195
Vasilios PapademetriouDepartment of Veterans Affairs and Georgetown University Medical Centers, Washington, DC (V.P.).
Ajay J KirtaneColumbia University Irving Medical Center/New York-Presbyterian Hospital, New York' NY (A.J.K.).ORCID 0000-0003-0061-1058
Joost DaemenThoraxcenter, Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands (J.D., E.S.).ORCID 0000-0001-8628-1410
Atul PathakDepartment of Cardiovasculaire Medicine, European Society of Hypertension Excellence Center, Princess Grace Hospital, Monaco (A.P.).
Christian UkenaKlinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany (F.M., M. Böhm, C.U.).ORCID 0000-0002-9810-4662
Philipp LurzHeart Center Leipzig at University of Leipzig, Germany (P.L.).ORCID 0000-0002-5993-4487
Guido GrassiClinica Medica University Milano-Bicocca, Milan, Italy (G.G.).ORCID 0000-0003-1922-6547
Martin MyersDivision of Cardiology, Sunnybrook Health Sciences Centre (M.M.), University of Toronto, Canada.ORCID 0000-0003-0468-5417
Aloke V FinnCVPath Institute, Gaithersburg, MD (A.V.F.).ORCID 0000-0003-0359-0184
Marie-Claude MoriceCERC, Paris, France (M.-C.M.).
Roxana MehranCardiovascular Research Foundation, New York (A.J.K., R.M., G.W.S.).ORCID 0000-0002-5546-262X
Peter JüniApplied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation (P.J.), University of Toronto, Canada.ORCID 0000-0002-5985-0670
Gregg W StoneCardiovascular Research Foundation, New York (A.J.K., R.M., G.W.S.).ORCID 0000-0002-3416-8210
Mitchell W KrucoffDuke Clinical Research Institute, Durham, NC (M.K.).
Paul K WheltonDepartments of Epidemiology and Medicine, Tulane University Health Sciences Center, New Orleans, LA (P.K.W.).ORCID 0000-0002-2225-383X
Konstantinos Tsioufis1st Department of Cardiology, National and Kapodistrian University of Athens, Hippocratio Hospital, Greece (K.T.).ORCID 0000-0002-7636-6725
Donald E CutlipBaim Institute for Clinical Research, Boston, MA (D.E.C.).ORCID 0000-0002-7583-9893
Ernest SpitzerCardialysis, Rotterdam, The Netherlands (J.D., E.S.).ORCID 0000-0003-2371-5431
Piedmont Atlanta Hospital · USUniversitätsklinikum des Saarlandes · DEBeth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USCardialysis (Netherlands) · NLCardiovascular Research Foundation · USCentre d’études des Mondes Russe, Caucasien et Centre-Européen · FRClinical Research Institute · USCVPath Institute · USErasmus MC · NLFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGeorgetown University · USHippocration General Hospital · GRInserm · FRIRCCS Istituto Auxologico Italiano · ITLeipzig Heart Institute · DEMount Sinai Hospital · USNewYork–Presbyterian Hospital · USPrincess Grace Hospital Centre · MCQueen Mary University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount. The Hypertension Academic Research Consortium (HARC) document represents an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspectives on clinical trial design and methodology. The HARC document integrates the collective information among device-based therapies for hypertension to better address existing challenges and identify unmet needs for technologies proposed to treat the world's leading cause of death and disability. Consistent with the Academic Research Consortium charter, this document proposes pragmatic consensus clinical design principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies.

Indexed as

HypertensionClinical Trials as TopicHumansclinical trialshypertensionoutcomesrenal denervation

Identifiers

PMID35286164
PMCPMC8912966
OpenAlexW4220851619

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.