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Dilated CardiomyopathyPhase 4NCT01917149

Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy

A Phase 4 study testing Benazepril, Valsartan and Metoprolol in people with Dilated Cardiomyopathy, run by Xijing Hospital at 1 site in China.

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

Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is the most common indication for heart transplantation worldwide. Despite advances in medical and device therapy, the 5-year mortality of patients with DCM remains high. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dilated Cardiomyopathy
What is being tested?
Benazepril, Valsartan and Metoprolol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteChina
Study dates
Mar 2005to Dec 2013
Phase
Phase 4
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of dilated cardiomyopathy
  • Left ventricular ejection fraction < 35%
  • NYHA Functional classes of II-IV
  • Symptomatic but not rapidly deteriorating 1 month before enrollment
  • Signed informed consent

Who cannot join

  • Contradictions and intolerance of the studied drugs:
  • supine systolic arterial blood pressure < 90 mmHg,
  • renal artery stenosis >50%,
  • pregnancy or lactation,
  • impaired renal function (estimated glomerular filtration rate < 60 ml/min/1.73m2,
  • impaired liver function (total bilirubin >2 times upper limit of normal,
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  • serum aspartate AST or alanine ALT >3 times the upper limit of normal),
  • hemoglobin less than 8 mg/dl, hyperkalaemia (serum potassium >5.5mmol/l),
  • obstructive lung disease,
  • advanced atrioventricular block,
  • any co-morbidity with impact on survival, and
  • known intolerance to benazepril, valsartan and metoprolol succinate;
  • HF secondary to a known cause:
  • coronary artery disease based on coronary angiography (≥50% stenosis in ≥1 of the major coronary arteries) and/or a history of myocardial infarction or angina pectoris,
  • acute or subacute stage of myocarditis,
  • primary valve disease,
  • diabetes mellitus,
  • excessive use of alcohol or illicit drugs;
  • Expected or performed cardiac resynchronization therapy and heart transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital, Department of Cardiology

    Xi'an, 710032

Other trials in China

About this study

Official title: Efficacy and Safety Study of Supramaximal Titrated Inhibition of RAAS in Idiopathic Dilated Cardiomyopathy

Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is the most common indication for heart transplantation worldwide. Despite advances in medical and device therapy, the 5-year mortality of patients with DCM remains high.

Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and left ventricular ejection fraction(LVEF) <35% were selected for randomized controlled study of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause death or admission for heart failure. Additional prespecified outcomes included all-cause death, cardiovascular death, all-cause admission, heart failure admission. Secondary cardiovascular outcomes included the changes from baseline to the last available observation after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral regurgitation and wall-motion score index assessed by ECG. Adverse events were reported during in-hospital observation and follow-ups.

Being tested
Benazepril, Valsartan, Metoprolol
Keywords
Dilated cardiomyopathy, High dose ACEI/ARB
Medical subject headings
Cardiomyopathy, Dilated

What participants receive

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

  • BenazeprilDrug

  • ValsartanDrug

  • MetoprololDrug

Study groups in NCT01917149
Study groupRoleWhat they receive
MetoprololExperimentalPatients in the metoprolol group were started on 11.875-23.75mg of metoprolol succinct extended-release tablet once daily (11.875mg was recommended for patients with NYHA functional classes III-IV), and then doses were doubled every 2 weeks to achieve asymptomatic bradycardia (50-60 bpm of heart rate) over 4-6 weeks. Investigators were encouraged to up-titrate metoprolol to a maximum dose of 190mg whenever possible.
Receives: Drug: Metoprolol
Low-dose valsartanExperimentalPatients randomized to low dose valsartan receive valsartan 80 mg until study completion.
Receives: Drug: Valsartan
Low dose BenazeprilExperimentalPatients randomized to low dose Benazepril receive Benazepril 10 mg until study completion.
Receives: Drug: Benazepril
High dose valsartanExperimentalPatients randomized to high-dose valsartan were started on valsartan 80mg twice daily, and uptitrated to target doses within 7 days under in-hospital observation. The target high doses of valsartan is determined by left-ventricular end-diastolic diameter (LVEDD) (the maximal value of anteroposterior and lateral diameters) obtained by ECG at the randomization visit. A target dose of valsartan 320mg, 480mg, 640mg daily were assigned to patients with LVEDD of 50-59, 60-69, ≥70 mm respectively.
Receives: Drug: Valsartan
High dose BenazeprilExperimentalPatients randomized to high-dose benazepril were started on benazepril 10mg twice daily, and uptitrated to target doses within 7 days under in-hospital observation. The target high doses of benazepril is determined by left-ventricular end-diastolic diameter (LVEDD) (the maximal value of anteroposterior and lateral diameters) obtained by ECG at the randomization visit. A target dose of benazepril 40mg, 60mg, 80mg daily were assigned to patients with LVEDD of 50-59, 60-69, ≥70 mm respectively.
Receives: Drug: Benazepril

What is being measured

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

  1. All cause death or admission for heart failure

    Admission for heart failure was defined as a minimum of 24 h inpatient admission to any health-care facility, with the primary cause being treated for worsening heart failure and during which an additional diuretic drug, intravenous or oral nitrate, or intravenous inotropic agent was given.

    Measured: 48 months after enrollment

Secondary outcomes (3)

  1. Changes in NYHA functional class

    Measured: 6,12, 24 and 36 months after enrollment

  2. Left-ventricular ejection fraction

    Left ventricular ejection fraction (LVEF) were calculated from measurements of left ventricular end diastolic and end systolic volumes in apical 4 and 2 chamber views using the modified Simpson's rule according to current guidelines

    Measured: 6,12, 24 and 36 months after enrollment

  3. Left-ventricular end-diastolic diameter

    Measured: 6, 12 , 24 and 36 months after enrollment

Timeline

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

  1. First posted6 Aug 2013 (estimated)
  2. Study startMar 2005
  3. Primary completionJul 2013
  4. Study completionDec 2013

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917149
Sponsor's protocol ID
SIRAAS-DC
Status last verified
May 2014
First submitted
30 Jul 2013
Last updated
19 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • He Z, Sun Y, Gao H, Zhang J, Lu Y, Feng J, Su H, Zeng C, Lv A, Cheng K, Li Y, Li H, Luan R, Wang L, Yu Q. Efficacy and safety of supramaximal titrated inhibition of renin-angiotensin-aldosterone system in idiopathic dilated cardiomyopathy. ESC Heart Fail. 2015 Dec;2(4):129-138. doi: 10.1002/ehf2.12042. Epub 2015 Jul 14.

    PubMed 28834619

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Benazepril, Valsartan and Metoprolol in people with Dilated Cardiomyopathy, run by Xijing Hospital at 1 site in China.

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 19 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

All cause death or admission for heart failure (time frame: 48 months after enrollment). 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 NCT01917149, 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 19 May 2014.

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