Heart DiseasesNCT00005201
Idiopathic Dilated Cardiomyopathy
An observational study of Heart Diseases and Cardiomyopathy, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Heart Diseases, Cardiomyopathy, Congestive
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1987to Jun 1992
- Phase
- Observational
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy.
Read the detailed description
BACKGROUND:
In 1987 idiopathic dilated cardiomyopathy was a disorder of unknown cause that directly affected one or both cardiac ventricles in a diffuse or multifactorial fashion, and that produced heart failure, at least in some patients. Although a viral etiology had been proposed, dilated cardiomyopathy could be associated with numerous genetic and non-genetic diseases. However in 1987, the role of genetic factors was not known in humans. Although the condition was usually dismissed as sporadic, numerous families with multiple affected members have been observed.
The role of atrial natriuretic peptide levels in the pathogenesis or progression of idiopathic dilated cardiomyopathy was just beginning to be explored in 1987. Although Syrian hamster studies did not suggest a genetic deficiency as the primary cause of dilated cardiomyopathy in that model, it was thought possible that ANP production or levels were somehow involved in how the myocardium responds in idiopathic dilated cardiomyopathy patients.
DESIGN NARRATIVE:
Eligible patients were interviewed and asked whether any first-degree relatives were willing to participate. If family members participated, a three generation pedigree was constructed and first-degree relatives contacted. The relatives were interviewed for a medical history and medical records from other institutions were reviewed. Each family member had a brief cardiovascular examination, a 12-lead electrocardiogram and 2-dimensional, M-mode, and Doppler echocardiogram. Blood was drawn for determination of atrial natriuretic peptide (ANP) levels. The contributions of variability in age, sex, drug use, smoking, and other concomitants to variability in ANP and echocardiographic data were estimated. After removing these sources of variability, the strength of similarity among family members was assessed. The relative contributions of genes and shared environments to the similarity among family members were estimated.
Heterogeneity in the mean levels of echocardiographic indices and ANP levels, familial aggregation and etiology of aggregation were assessed between families with familial idiopathic dilated cardiomyopathy and families with non-familial idiopathic dilated cardiomyopathy.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Heart Diseases, Cardiomyopathy, Congestive
- Medical subject headings
- Heart Diseases, Cardiomyopathy, Dilated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1987
- Study completionJun 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005201
- Sponsor's protocol ID
- 1080
- Other IDs
- R01HL036879
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Michels VV, Moll PP, Miller FA, Tajik AJ, Chu JS, Driscoll DJ, Burnett JC, Rodeheffer RJ, Chesebro JH, Tazelaar HD. The frequency of familial dilated cardiomyopathy in a series of patients with idiopathic dilated cardiomyopathy. N Engl J Med. 1992 Jan 9;326(2):77-82. doi: 10.1056/NEJM199201093260201.
PubMed 1727235Michels VV, Moll PP, Rodeheffer RJ, Miller FA Jr, Tajik AJ, Burnett JC Jr, Driscoll DJ, Thibodeau SN, Ansari AA, Herskowitz A. Circulating heart autoantibodies in familial as compared with nonfamilial idiopathic dilated cardiomyopathy. Mayo Clin Proc. 1994 Jan;69(1):24-7. doi: 10.1016/s0025-6196(12)61607-3.
PubMed 8271845
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00005201
- Acronym / sponsor ID
- 1080
- Conditions
- Heart Diseases, Cardiomyopathy, Congestive
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1987
- Study completion
- Jun 1992 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy.
Detailed description
BACKGROUND:
In 1987 idiopathic dilated cardiomyopathy was a disorder of unknown cause that directly affected one or both cardiac ventricles in a diffuse or multifactorial fashion, and that produced heart failure, at least in some patients. Although a viral etiology had been proposed, dilated cardiomyopathy could be associated with numerous genetic and non-genetic diseases. However in 1987, the role of genetic factors was not known in humans. Although the condition was usually dismissed as sporadic, numerous families with multiple affected members have been observed.
The role of atrial natriuretic peptide levels in the pathogenesis or progression of idiopathic dilated cardiomyopathy was just beginning to be explored in 1987. Although Syrian hamster studies did not suggest a genetic deficiency as the primary cause of dilated cardiomyopathy in that model, it was thought possible that ANP production or levels were somehow involved in how the myocardium responds in idiopathic dilated cardiomyopathy patients.
DESIGN NARRATIVE:
Eligible patients were interviewed and asked whether any first-degree relatives were willing to participate. If family members participated, a three generation pedigree was constructed and first-degree relatives contacted. The relatives were interviewed for a medical history and medical records from other institutions were reviewed. Each family member had a brief cardiovascular examination, a 12-lead electrocardiogram and 2-dimensional, M-mode, and Doppler echocardiogram. Blood was drawn for determination of atrial natriuretic peptide (ANP) levels. The contributions of variability in age, sex, drug use, smoking, and other concomitants to variability in ANP and echocardiographic data were estimated. After removing these sources of variability, the strength of similarity among family members was assessed. The relative contributions of genes and shared environments to the similarity among family members were estimated.
Heterogeneity in the mean levels of echocardiographic indices and ANP levels, familial aggregation and etiology of aggregation were assessed between families with familial idiopathic dilated cardiomyopathy and families with non-familial idiopathic dilated cardiomyopathy.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 1727235Michels VV, Moll PP, Miller FA, Tajik AJ, Chu JS, Driscoll DJ, Burnett JC, Rodeheffer RJ, Chesebro JH, Tazelaar HD. The frequency of familial dilated cardiomyopathy in a series of patients with idiopathic dilated cardiomyopathy. N Engl J Med. 1992 Jan 9;326(2):77-82. doi: 10.1056/NEJM199201093260201.
- Background: PubMed 8271845Michels VV, Moll PP, Rodeheffer RJ, Miller FA Jr, Tajik AJ, Burnett JC Jr, Driscoll DJ, Thibodeau SN, Ansari AA, Herskowitz A. Circulating heart autoantibodies in familial as compared with nonfamilial idiopathic dilated cardiomyopathy. Mayo Clin Proc. 1994 Jan;69(1):24-7. doi: 10.1016/s0025-6196(12)61607-3.
Related trials for Heart Diseases
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Not yet recruitingObservational study
NHLBI-Emory Advanced Cardiac CT Reconstruction
Structural Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Cardiomyopathy, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005201, which also lists 2 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 13 May 2016.