AzTrials
AzTrials

Heart FailurePhase 2NCT01951638

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

A Phase 2 study testing Vericiguat (BAY1021189) (1.25 mg) and Vericiguat (BAY1021189) (5 mg) in people with Heart Failure, run by Bayer at 158 sites in 25 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

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Vericiguat (BAY1021189) (1.25 mg) and Vericiguat (BAY1021189) (5 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
477 participants
Where
158 sitesin 25 countries
Study dates
6 Nov 2013to 16 Sep 2015
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

  • Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
  • Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization

Who cannot join

  • Intravenous inotropes at any time after hospitalization

Trial locations and contacts

158 sites in 25 countries.

158 sites in 25 countries

Japan22 sites

  • Study site

    Fukui, 910-8526

  • Study site

    Higashiibaraki, Ibaraki, 311-3193

  • Study site

    Himeji, Hyōgo, 670-0981

  • Study site

    Hiroshima, 734-8530

  • Study site

    Iizuka, Fukuoka, 820-8505

  • Study site

    Kanazawa, Ishikawa-ken, 920-8650

  • Study site

    Komatsushimachō, Tokushima, 773-8502

  • Study site

    Kumamoto, 862-8505

  • Study site

    Meguro-ku, Tokyo, 152-8902

  • Study site

    Minato-ku, Tokyo, 106-0031

  • Study site

    Nagasaki, 850-8555

  • Study site

    Naha, Okinawa, 902-8511

  • Study site

    Osaka, 558-8558

  • Study site

    Sagamihara, Kanagawa, 252-5188

  • Study site

    Sakai, Osaka, 599-8247

  • Study site

    Takamatsu, Kagawa-ken, 760-0018

  • Study site

    Takatsuki, Osaka, 569-1096

  • Study site

    Tokushima, 770-8539

  • Study site

    Toyama, 930-8550

  • Study site

    Uji, Kyoto, 611-0041

  • Study site

    Yokohama, Kanagawa, 236-0051

  • Study site

    Yokosuka, Kanagawa, 238-8567

Other trials in Japan

United States17 sites

  • Study site

    Buffalo, New York, 14215

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chicago, Illinois, 60611-2908

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jackson, Mississippi, 39216-4505

  • Study site

    Macon, Georgia, 31201

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Minneapolis, Minnesota, 55422

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37232-8802

  • Study site

    New Orleans, Louisiana, 70112-1396

  • Study site

    Newark, New Jersey, 07103

  • Study site

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

Germany10 sites

  • Study site

    Bad Homburg, Hesse, 61348

  • Study site

    Bad Krozingen, Baden-Wurttemberg, 79189

  • Study site

    Cologne, North Rhine-Westphalia, 50937

  • Study site

    Erfurt, Thuringia, 99089

  • Study site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg, Saarland, 66421

  • Study site

    München, Bavaria, 80331

  • Study site

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Israel10 sites

  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7830604

  • Study site

    Hadera, 3810101

  • Study site

    Haifa, 3109601

  • Study site

    Jerusalem, 9103102

  • Study site

    Petah Tikva, 4941492

  • Study site

    Rehovot, 7610001

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tiberias, 1528001

  • Study site

    Zrifin, 7030000

Other trials in Israel

Belgium8 sites

  • Study site

    Bruges, 8000

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Ghent, 9000

  • Study site

    Gilly, 6060

  • Study site

    Huy, 4500

  • Study site

    Mechelen, 2800

  • Study site

    Mol, 2400

  • Study site

    Roeselare, 8800

Other trials in Belgium

Poland8 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Krakow, 31-121

  • Study site

    Krakow, 31-202

  • Study site

    Lodz, 92-213

  • Study site

    Lodz, 93-513

  • Study site

    Olsztyn, 10-010

  • Study site

    Poznan, 61-848

  • Study site

    Szczecin, 70-965

Other trials in Poland

Austria7 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Salzburg, 5020

  • Study site

    Sankt Pölten, Lower Austria, 3100

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1220

Other trials in Austria

Italy7 sites

  • Study site

    Ancona, The Marches, 60126

  • Study site

    Arezzo, Tuscany, 52040

  • Study site

    Bergamo, Lombardy, 24127

  • Study site

    Brescia, Lombardy, 25123

  • Study site

    Milan, Lombardy, 20017

  • Study site

    Milan, Lombardy, 20149

  • Study site

    Pavia, Lombardy, 27100

Other trials in Italy

Spain7 sites

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08023

  • Study site

    El Palmar, Murcia, 30120

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46026

Other trials in Spain

Bulgaria6 sites

  • Study site

    Burgas, 8018

  • Study site

    Sofia, 1202

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1309

  • Study site

    Sofia, 1527

  • Study site

    Stara Zagora, 6000

Other trials in Bulgaria

Canada6 sites

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Québec, G1V 4G5

  • Study site

    Saint-Jean-sur-Richelieu, Quebec, J3A 1C3

  • Study site

    Sherbrooke, Quebec, J1G 2E8

  • Study site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Australia5 sites

  • Study site

    Brisbane, Queensland, 4029

  • Study site

    Brisbane, Queensland, 4064

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Redcliffe, Queensland, 4020

Other trials in Australia

Czechia5 sites

  • Study site

    Kroměříž, 767 01

  • Study site

    Prague, 10034

  • Study site

    Prague, 12808

  • Study site

    Prague, 140 21

  • Study site

    Prague, 169 02

Other trials in Czechia

Sweden5 sites

  • Study site

    Helsingborg, 251 87

  • Study site

    Karlstad, 652 30

  • Study site

    Linköping, 581 85

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 118 83

Other trials in Sweden

Taiwan5 sites

  • Study site

    Kaohsiung City, 813

  • Study site

    New Taipei City, 220

  • Study site

    Taipei, 10016

  • Study site

    Taipei, 11217

  • Study site

    Taoyuan, 333423

Other trials in Taiwan

France4 sites

  • Study site

    Bron, 69677

  • Study site

    Pessac, 33604

  • Study site

    Rouen, 76031

  • Study site

    Toulouse, 31403

Other trials in France

Netherlands4 sites

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Heerenveen, 8441 PW

  • Study site

    Leeuwarden, 8934 AD

  • Study site

    Sneek, 8601 ZR

Other trials in Netherlands

Portugal4 sites

  • Study site

    Almada, 2801-951

  • Study site

    Lisbon, 1449-005

  • Study site

    Lisbon, 1500-650

  • Study site

    Lisbon, 1649-035

Other trials in Portugal

Singapore4 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 169609

  • Study site

    Singapore, 308433

  • Study site

    Singapore, 768828

Other trials in Singapore

Denmark3 sites

  • Study site

    Aalborg, 9000

  • Study site

    Holbæk, 4300

  • Study site

    Randers, 8930

Other trials in Denmark

Greece3 sites

  • Study site

    Athens, 11527

  • Study site

    Chaïdári, 12462

  • Study site

    Nea Ionia / Athens, 142 33

Other trials in Greece

Hungary3 sites

  • Study site

    Budapest, 1097

  • Study site

    Kistarcsa, H-2143

  • Study site

    Székesfehérvár, 8000

Other trials in Hungary

Switzerland2 sites

  • Study site

    Geneva, 1205

  • Study site

    Lugano, Canton Ticino, 6900

Other trials in Switzerland

United Kingdom2 sites

  • Study site

    Chesterfield, Derbyshire, S44 5DX

  • Study site

    Stevenage, Hertfordshire, SG1 4AB

Other trials in United Kingdom

South Korea1 site

  • Study site

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure and Preserved Ejection Fraction (HFpEF)

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

Conditions
Heart Failure
Being tested
Vericiguat (BAY1021189) (1.25 mg), Vericiguat (BAY1021189) (5 mg), Placebo
Keywords
Worsening Heart Failure, Heart Failure with Preserved Ejection Fraction
Medical subject headings
Heart Failure

What participants receive

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

  • Vericiguat (BAY1021189) (1.25 mg)Drug

    1.25 mg BAY1021189 tablets

  • Vericiguat (BAY1021189) (5 mg)Drug

    5 mg BAY1021189 tablets

  • PlaceboDrug

Study groups in NCT01951638
Study groupRoleWhat they receive
Vericiguat (BAY1021189)(10 mg)Experimental2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg); Drug: Vericiguat (BAY1021189) (5 mg)
Vericiguat (BAY1021189) (5 mg)Experimental2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg); Drug: Vericiguat (BAY1021189) (5 mg)
Vericiguat (BAY1021189) (2.5 mg)Experimental2.5 mg orally once daily for 12 weeks (with sham titrations)
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg)
Vericiguat (BAY1021189) (1.25 mg)Experimental1.25 mg orally once daily for 12 weeks (with sham titrations)
Receives: Drug: Vericiguat (BAY1021189) (1.25 mg)
PlaceboPlacebo comparatorOrally once daily for 12 weeks (with sham titrations)
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

    NTproBNP is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure (HF).

    Measured: Baseline, Week 12 (end of treatment [EOT])

  2. Change From Baseline to Week 12 in Left Atrial Volume (LAV)

    Left atrial volume was measured by echocardiography.

    Measured: Baseline, Week 12 (EOT)

Timeline

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

  1. First posted26 Sep 2013 (estimated)
  2. Study start6 Nov 2013
  3. Primary completion18 Aug 2015
  4. Study completion16 Sep 2015

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
477 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951638
Sponsor's protocol ID
15829
Other IDs
2013-002288-25
Status last verified
Feb 2021
First submitted
24 Sep 2013
Last updated
16 Mar 2021
Data monitoring committee
Yes

Publications

  • Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Muller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.

    PubMed 25056511

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vericiguat (BAY1021189) (1.25 mg) and Vericiguat (BAY1021189) (5 mg) in people with Heart Failure, run by Bayer at 158 sites in 25 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 2 inclusion and 1 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in Japan, United States, Germany, Israel, Belgium and 20 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 12 Feb 2021). 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?

Change From Baseline to Week 12 in Log-transformed N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) (time frame: Baseline, Week 12 (end of treatment [EOT])). The study lists 2 primary outcomes in all. 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 NCT01951638, 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 16 Mar 2021.

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