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Heart FailurePhase 2ARTSNCT01345656

BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease

A Phase 2 study testing BAY94-8862 and Spironolactone in people with Heart Failure, run by Bayer at 50 sites in 10 countries.

Completed

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

Official record
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Trial summary

A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally 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?
BAY94-8862 and Spironolactone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
457 participants
Where
50 sitesin 10 countries
Study dates
9 May 2011to 16 Jul 2012
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
  • Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
  • Known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and
  • Part A: 60 mL/min/1.73 m*2 </= eGFR (estimated Glomerular Filtration Rate) < 90 mL/min/1.73 m*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
  • Part B: 30 mL/min/1.73 m*2 </= eGFR <= 60 mL/min/1.73 m*2 (MDRD) at the screening visit
  • Serum potassium </= 4.8 mmol/L at the screening visit
  • Systolic blood pressure >/= 90 mmHg without signs or symptoms of hypotension at the screening visit

Who cannot join

  • Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
  • Subjects with anuria, acute renal failure, or Addison's disease
  • Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
  • Valvular heart disease requiring surgical intervention during the course of the study
  • History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment

Trial locations and contacts

50 sites in 10 countries.

50 sites in 10 countries

Denmark11 sites

  • Study site

    Copenhagen Ø, 2100

  • Study site

    Esbjerg, 6700

  • Study site

    Frederiksberg, 2000

  • Study site

    Hellerup, 2900

  • Study site

    Herlev, 2730

  • Study site

    Hvidovre, 2650

  • Study site

    København NV, 2400

  • Study site

    Køge, 4600

  • Study site

    Odense, 5000

  • Study site

    Svendborg, 5700

  • Study site

    Viborg, 8800

Other trials in Denmark

Germany7 sites

  • Study site

    Berlin, 13353

  • Study site

    Cologne, North Rhine-Westphalia, 50968

  • Study site

    Dresden, Saxony, 01277

  • Study site

    Erfurt, Thuringia, 99084

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Wedel, Schleswig-Holstein, 22880

  • Study site

    Wermsdorf, Saxony, 04779

Other trials in Germany

Israel7 sites

  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7830604

  • Study site

    Hadera, 3810101

  • Study site

    Petah Tikva, 4941492

  • Study site

    Rehovot, 7610001

  • Study site

    Safed, 1311001

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Poland5 sites

  • Study site

    Krakow, 30-082

  • Study site

    Piotrkow Trybunalski, 97-635

  • Study site

    Szczecin, 70-965

  • Study site

    Warsaw, 04-635

  • Study site

    Wroclaw, 50-981

Other trials in Poland

Sweden5 sites

  • Study site

    Kristianstad, 29185

  • Study site

    Lund, 222 21

  • Study site

    Stockholm, 111 35

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm

Other trials in Sweden

Czechia4 sites

  • Study site

    Brno, 625 00

  • Study site

    Liberec, 460 63

  • Study site

    Prague, 12808

  • Study site

    Prague, 15030

Other trials in Czechia

Austria3 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Vienna, 1100

Other trials in Austria

Belgium3 sites

  • Study site

    Brasschaat, 2930

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Roeselare, 8800

Other trials in Belgium

Finland3 sites

  • Study site

    Helsinki, FIN-00260

  • Study site

    Jyväskylä, FI-40620

  • Study site

    Turku, FIN-20520

Other trials in Finland

Norway2 sites

  • Study site

    Oslo, 0450

  • Study site

    Stavanger

Other trials in Norway

About this study

Official title: A Randomized, Double-blind, Multi-center Study to Assess Safety and Tolerability of Different Oral Doses of BAY94-8862 in Subjects With Stable Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease Versus Placebo (Part A) or Versus Placebo and Spironolactone (Part B)

A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally

Conditions
Heart Failure
Being tested
BAY94-8862, Placebo, Spironolactone
Keywords
Chronic Heart Failure
Medical subject headings
Heart Failure

What participants receive

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

  • BAY94-8862Drug

    Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks

  • BAY94-8862Drug

    Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks

  • BAY94-8862Drug

    One 10 mg BAY94-8862 tablet for duration of 4 weeks

  • BAY94-8862Drug

    Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks

  • PlaceboDrug

    Placebo tablets for duration of 4 weeks

  • SpironolactoneDrug

    Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks

Study groups in NCT01345656
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: BAY94-8862
Arm 2ExperimentalNot described
Receives: Drug: BAY94-8862
Arm 3ExperimentalNot described
Receives: Drug: BAY94-8862
Arm 4ExperimentalNot described
Receives: Drug: BAY94-8862
Arm 5Placebo comparatorNot described
Receives: Drug: Placebo
Arm 6Active comparatorNot described
Receives: Drug: Spironolactone

What is being measured

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

  1. Change of serum potassium

    Measured: 4 weeks

Secondary outcomes (3)

  1. Change in serum magnesium

    Measured: Day 8, Day 15, Day 22, Day 29

  2. Change in blood pressure

    Measured: Day 8, Day 15, Day 22, Day 29

  3. Change in heart rate

    Measured: Day 8, Day 15, Day 22, Day 29

Timeline

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

  1. First posted2 May 2011 (estimated)
  2. Study start9 May 2011
  3. Primary completion30 May 2012
  4. Study completion16 Jul 2012

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
457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345656
Sponsor's protocol ID
14563
Other IDs
2011-000301-45
Acronym
ARTS
Status last verified
Jan 2022
First submitted
29 Apr 2011
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Pitt B, Filippatos G, Gheorghiade M, Kober L, Krum H, Ponikowski P, Nowack C, Kolkhof P, Kim SY, Zannad F. Rationale and design of ARTS: a randomized, double-blind study of BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease. Eur J Heart Fail. 2012 Jun;14(6):668-75. doi: 10.1093/eurjhf/hfs061. Epub 2012 May 4.

    PubMed 22562554

  • Pitt B, Kober L, Ponikowski P, Gheorghiade M, Filippatos G, Krum H, Nowack C, Kolkhof P, Kim SY, Zannad F. Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial. Eur Heart J. 2013 Aug;34(31):2453-63. doi: 10.1093/eurheartj/eht187. Epub 2013 May 27.

    PubMed 23713082

  • Ostrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2026 Feb 1;37(2):312-325. doi: 10.1681/ASN.0000000823. Epub 2025 Sep 12.

    PubMed 40938666

  • Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

    PubMed 33107592

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY94-8862 and Spironolactone in people with Heart Failure, run by Bayer at 50 sites in 10 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 7 inclusion and 5 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Denmark, Germany, Israel, Poland, Sweden and 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of serum potassium (time frame: 4 weeks). 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 NCT01345656, which also lists 4 linked publications.

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 10 Feb 2022.

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