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Heart Failure With Preserved Ejection FractionPhase 2SERENADENCT03153111

A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

A Phase 2 study testing Macitentan in people with Heart Failure With Preserved Ejection Fraction, run by Actelion at 95 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Macitentan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
143 participants
Where
95 sitesin 17 countries
Study dates
11 Jul 2017to 12 Mar 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signs or symptoms of Heart Failure (HF) (NYHA FC I I and II I ) requiring treatment with at least one oral diuretic (any type)
  • Left ventricular ejection fraction (LVEF) ≥ 40% (by echocardiography at Screening)
  • Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening
  • Elevated NT-proBNP
  • Pulmonary vascular disease or right ventricular dysfunction

Who cannot join

  • Any prior valid measurement of LVEF < 40%. An echocardiogram is considered valid if its quality is sufficient to allow accurate assessment of LVEF and if it is reflective of the true status of the subject
  • Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc)
  • Systolic blood pressure (SBP) ≥ 180 mmHg, or diastolic blood pressure (DBP) ≥ 110 mmHg during Screening
  • Hemoglobin < 100g/L (< 10 g/dl) at Screening
  • Significant parenchymal lung disease (e.g., severe COPD, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism)
  • Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2
  • Severe hepatic impairment, e.g., Child Pugh Class C
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

95 sites in 17 countries.

95 sites in 17 countries

United States24 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • AnMed Health

    Anderson, South Carolina, 29621

  • Peak Clinical Trials

    Apex, North Carolina, 27502

  • University of Maryland

    Baltimore, Maryland, 21201

  • Cedars Sinai Heart Institute

    Beverly Hills, California, 90211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina (UNC) - School of Medicine

    Chapel Hill, North Carolina, 27599

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219-2906

  • Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

  • University Of Iowa - Hospitals & Clinics

    Iowa City, Iowa, 52242-1081

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • Aurora Saint Lukes Medical Center

    Milwaukee, Wisconsin, 53215

  • Weill Cornell Medicine

    New York, New York, 10021

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Allegheny

    Pittsburgh, Pennsylvania, 15212

  • Vascular Medicine Institute University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • MultiCare Health System

    Tacoma, Washington, 98405

  • Baylor Scott and White Research Institute

    Temple, Texas, 76508

  • Harbor Ucla Medical Center

    Torrance, California, 90502

Other trials in United States

Israel8 sites

  • Barzilai Medical Center

    Ashkelon

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Wolfson Medical Center

    Holon

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Galilee Medical Center

    Nahariya, 2210001

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7610001

Other trials in Israel

Russia8 sites

  • Federal State Budget Scientific Institution

    Kemerovo, 650002

  • Krasnodar Regional Clinical Hospital

    Krasnodar, 350086

  • Moscow City Clinical Hospital No.51

    Moscow, 121309

  • National Medical Research Center of Cardiology of MoH of Russian Federation

    Moscow, 121552

  • Federal State Budgetary Institution

    Saint Petersburg, 197341

  • State Healthcare Institution, Regional Clinical Cardiology Dispensary

    Saratov, 410028

  • State Autonomous Healthcare Institution Of Yaroslavl Region

    Yaroslavl, 150003

  • Ekaterinburg City Clinical Hospital #14

    Yekaterinburg, 620039

Other trials in Russia

Germany7 sites

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353

  • Universitatsklinikum Bonn

    Bonn, 53105

  • Herzzentrum Uniklinik Köln Klinik III für Innere Medizin

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

    Dresden, 01307

  • Universitaetsklinikum Giessen

    Giessen, 35392

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

  • Klinikum Würzburg Mitte gGmbH Standort Missioklinik

    Würzburg, 97074

Other trials in Germany

Brazil5 sites

  • Maestri E Kormann Consultoria Médico- Científica Ltda

    Blumenau, 89020-430

  • Rede D or Sao Luiz S A Hospital do Coracao do Brasil

    Brasília, 70390-700

  • Instituto de Pesquisa Clinica de Campinas

    Campinas, 13060-080

  • Instituto do Coracao de Marília

    Marília, 17515-000

  • Instituto de Moléstias Cardiovasculares Tatuí

    Tatuí, 18270-170

Other trials in Brazil

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Plzeň-Lochotín

    Pilsen, 304 60

  • General University Hospital II.department of Internal Medicine-cardiology and angiology

    Prague, 128 08

  • IKEM

    Prague, 140 21

Other trials in Czechia

France5 sites

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Grenoble Hopital Albert Michallon

    Grenoble, 38043

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270

  • Hopital Cardiologique

    Lille, 59037

  • CHU Rouen Hopital Charles Nicolle

    Rouen, 76031

Other trials in France

Spain5 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario La Fe

    Valencia, 46026

Other trials in Spain

Argentina4 sites

  • Centro Médico Dra. De Salvo

    Buenos Aires, C1426ABP

  • CCBR - Buenos Aires - AR

    Buenos Aires, C1430CKE

  • Clinica Adventista Belgrano

    CABA, C1430EGF

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, B7600FZN

Other trials in Argentina

Bulgaria4 sites

  • Specialized Hospital for Active Treatment in Cardiology - Pleven

    Pleven, 5800

  • Diagnostic Consulting Center I Sliven

    Sliven, 8800

  • Multiprofile Hospital for Active Treatment - National Heart Hospital

    Sofia, 1309

  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

    Sofia, 1750

Other trials in Bulgaria

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 952

  • Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn

    Krakow, 31 202

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

    Lublin, 20 718

  • 4 Wojskowy Szpital Kliniczny Z Poliklinika SP ZOZ

    Wroclaw, 50 513

Other trials in Poland

Romania4 sites

  • Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu

    Bucharest, 022328

  • Cardiomed

    Craiova, 200505

  • SAL MED Pitesti

    Piteşti, 110437

  • Cmi Dr Podoleanu Cristian

    Târgu Mureş, 540503

Other trials in Romania

United Kingdom4 sites

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, CB2 0AY

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • Royal Free Hospital

    London, NW3 2QG

  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

    Sheffield, S10 2RX

Other trials in United Kingdom

Denmark3 sites

  • Aarhus Universitetshospital

    Aarhus, 8200

  • Bispebjerg Og Frederiksberg Hospital

    Copenhagen, 2400

  • Sydvestjysk Sygehus

    Esbjerg, 6700

Other trials in Denmark

Hungary3 sites

  • Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Semmelweis Egyetem Varosmajor Sziv es Ergyogyaszati Klinika

    Budapest, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1134

Other trials in Hungary

Austria1 site

  • Medizinische Universitaet Wien

    Vienna, 1090

Other trials in Austria

Sweden1 site

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 45

Other trials in Sweden

About this study

Official title: A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.

The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

Being tested
Macitentan, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MacitentanDrug

    Also called ACT-064992

    macitentan 10 mg; film-coated tablet; oral use

  • PlaceboDrug

    film-coated tablet (identical to the macitentan tablet); oral use

Study groups in NCT03153111
Study groupRoleWhat they receive
MacitentanActive comparatorSubjects randomized to the macitentan arm receives one tablet of macitentan 10 mg every day for at least 24 to maximum 52 weeks.
Receives: Drug: Macitentan
PlaceboPlacebo comparatorSubjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Baseline N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Assessed at Week 24

    Percent of baseline NT-proBNP assessed at Week 24 was reported. Percent of baseline is calculated as the ratio of the Week 24 NT-proBNP value over baseline value, expressed in percentage. NT-proBNP is one of the best established cardiovascular response markers among all available surrogates in heart failure (HF).

    Measured: Week 24

Secondary outcomes (3)

  1. Change From Baseline to Week 24 in the Clinical Summary Score Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

    The KCCQ is a validated health related quality of life measure for heart failure. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Clinical summary score is one of the quality of life variable of interest derived from KCCQ. Clinical summary score is the mean of domains: physical limitations score (6 items) and total symptom score (2 items [symptoms frequency and symptom burden]). The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.

    Measured: Baseline to Week 24

  2. Change From Baseline to Week 24 in Accelerometer-assessed Proportion of Time Spent in Light to Vigourous Physical Activity

    Physical activity is assessed by accelerometer as the proportion of time spent in light to vigorous physical activity based on a threshold of greater than (>)100 activity counts per minute and expressed as change from baseline to Week 24.

    Measured: Baseline to Week 24

  3. Number of Participants With Worsening of Heart Failure (WHF) Events Over 52 Weeks

    Number of participants with WHF events were reported. A WHF event includes HF death, hospitalization for WHF or an urgent visit for WHF.

    Measured: Weeks 16, 24, 36, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start11 Jul 2017
  3. Primary completion12 Mar 2021
  4. Study completion12 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03153111
Sponsor's protocol ID
AC-055G202
Other IDs
2016-003653-15, 2016
Acronym
SERENADE
Status last verified
Mar 2025
First submitted
30 Mar 2017
Last updated
30 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah SJ, Bonderman D, Borlaug BA, Cleland JGF, Lack G, Lu W, Voors AA, Zannad F, Gladwin MT. Macitentan for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Pulmonary Vascular Disease: Results of the SERENADE Randomized Clinical Trial and Open-Label Extension Study. Circ Heart Fail. 2025 Mar;18(3):e011381. doi: 10.1161/CIRCHEARTFAILURE.123.011381. Epub 2025 Mar 11.

    PubMed 40066571

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Macitentan in people with Heart Failure With Preserved Ejection Fraction, run by Actelion at 95 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Israel, Russia, Germany, Brazil and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Baseline N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Assessed at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03153111, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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