Chronic Heart FailureNCT01365325
Handled Echocardiography and Chronic Heart Failure
A study testing handled echocardiography in home monitoring program and ecg and clinical evaluation in home monitoring program in people with Chronic Heart Failure, run by Federico II University at 1 site in Italy.
Trial summary
The aim of the study is to compare two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations, the other one using also periodical handled echocardiographic examinations. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- handled echocardiography in home monitoring program and ecg and clinical evaluation in home monitoring program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Dec 2010
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Chronic Heart Failure in functional class NYHA III
- At least once hospitalization during the last year for worsening of clinical symptoms or for the appearance of acute cardiovascular events
- Patients who cannot easily reach the pertaining Sanitary District for different reasons (i.e. the presence of architectural barriers, the absence of a lift, a too great distance between home and Sanitary District without someone helping)
- age ≥ 70 years
- written informed consent
Who cannot join
- Patients who were waiting for cardiac surgery or patients who had undergone a cardiac operation within three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs
The aim of the study is to compare two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations, the other one using also periodical handled echocardiographic examinations.
Read the detailed description
Randomized, blinded, controlled, monocentric study comparing two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations every three months, the other one using also periodical handheld echocardiographic examinations at the 6th, 12th and 18th month.
The events occurring during the 18 month follow up and the results of the final echocardiography performed in all the patients will be transmitted to and evaluated by an independent observer, unaware of the features of the follow up. At the end of the trial, the randomization code will be opened and the events will be ascribed to the two groups. The primary end point is rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events during the 18 months follow up. Secondary end points include home treated vascular events, cardiovascular death and the composite end point death + rehospitalization.
- Conditions
- Chronic Heart Failure
- Being tested
- handled echocardiography in home monitoring program, ecg and clinical evaluation in home monitoring program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handled echocardiography in home monitoring programOther
Also called Handled echocardiography
home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month
ecg and clinical evaluation in home monitoring programOther
Also called home monitoring with clinical evaluations and ECG
home monitoring with clinical evaluations and ECG every three months
| Study group | Role | What they receive |
|---|---|---|
| handled echocardiography | Experimental | home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations Receives: Other: handled echocardiography in home monitoring program |
| home monitoring program | Active comparator | home monitoring care program based on clinical and electrocardiographic evaluations Receives: Other: ecg and clinical evaluation in home monitoring program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
Measured: 18 months
Secondary outcomes (3)
Home treated major vascular events
Number of Participants with major vascular events occurred during the 18 months follow up who did not go to the Hospital and were home treated
Measured: 18 months
Cardiovascular death
Measured: 18 months
Composite end point death + rehospitalization
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Ugo Oliviero, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365325
- Sponsor's protocol ID
- 228/08
- Status last verified
- Dec 2010
- First submitted
- 27 May 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs
- ClinicalTrials.gov ID
- NCT01365325
- Acronym / sponsor ID
- 228/08
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jun 2011 (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.
The aim of the study is to compare two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations, the other one using also periodical handled echocardiographic examinations.
Detailed description
Randomized, blinded, controlled, monocentric study comparing two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations every three months, the other one using also periodical handheld echocardiographic examinations at the 6th, 12th and 18th month.
The events occurring during the 18 month follow up and the results of the final echocardiography performed in all the patients will be transmitted to and evaluated by an independent observer, unaware of the features of the follow up. At the end of the trial, the randomization code will be opened and the events will be ascribed to the two groups. The primary end point is rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events during the 18 months follow up. Secondary end points include home treated vascular events, cardiovascular death and the composite end point death + rehospitalization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| handled echocardiography | Experimental | Other: handled echocardiography in home monitoring programhome monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations |
| home monitoring program | Active comparator | Other: ecg and clinical evaluation in home monitoring programhome monitoring care program based on clinical and electrocardiographic evaluations |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Chronic Heart Failure in functional class NYHA III
- At least once hospitalization during the last year for worsening of clinical symptoms or for the appearance of acute cardiovascular events
- Patients who cannot easily reach the pertaining Sanitary District for different reasons (i.e. the presence of architectural barriers, the absence of a lift, a too great distance between home and Sanitary District without someone helping)
- age ≥ 70 years
- written informed consent
Key exclusion criteria (1 listed)
- Patients who were waiting for cardiac surgery or patients who had undergone a cardiac operation within three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handled echocardiography in home monitoring programAlso: Handled echocardiographyhome monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month | Other | handled echocardiography |
| ecg and clinical evaluation in home monitoring programAlso: home monitoring with clinical evaluations and ECGhome monitoring with clinical evaluations and ECG every three months | Other | home monitoring program |
Primary outcome
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
Time frame: 18 months
3 secondary outcomes
Home treated major vascular events
Time frame: 18 months
Cardiovascular death
Time frame: 18 months
Composite end point death + rehospitalization
Time frame: 18 months
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 3 Jun 2011.
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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.
Ugo Oliviero, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing handled echocardiography in home monitoring program and ecg and clinical evaluation in home monitoring program in people with Chronic Heart Failure, run by Federico II University at 1 site in Italy.
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 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 3 Jun 2011. 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 Italy. 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.
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?
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2011.