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NCT Number: NCT03142659

Evaluation and Management of Heart Failure Patients

The investigator is trying to improving our knowledge in the treatment of HF patients, for the purpose of improving their quality of life and reducing hospitalizations. For achieving this the investigator would like to build a registry which will include all the HF patients going an evaluation in the Heart Failure unit or clinic in our facility,

Recruiting

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The prevalence of Heart Failure depends on the definition applied, but is approximately 1-2% of the adult population in developed countries, rising to ≥10% among people >70 years of age. Among people >65 years of age presenting to primary care with breathlessness on exertion, one in six will have unrecognized HF. The lifetime risk of HF at age 55 years is 33% for men and 28% for women. The most recent European data (ESC-HF pilot study) demonstrate that 12-month all-cause mortality rates for hospitalized and stable/ambulatory HF patients were 17% and 7%, respectively, and the 12-month hospitalization rates were 44% and 32%, respectively. Modifying risk factors and dynamic change of the medical treatment may improve symptoms, quality of life and reduce hospitalization due to HF exacerbation. For this cause, the Heat Failure unit was established. The goal of the Heart Failure unit is to provide medical and nursing follow-up for severe HF patients with New York Heart Association Function III-IV in purpose to improve their quality of life and reduce hospitalizations. At each visit the patients will be evaluated by a nurse and a cardiologist, blood tests will be performed and IV treatment will be given as needed, including Furosemide, Iron, Dobutamine and Packed Cells.

The investigator is trying to improving our knowledge in the treatment of HF patients, for the purpose of improving their quality of life and reducing hospitalizations. For achieving this the investigator would like to build a registry which will include all the HF patients going an evaluation in the Heart Failure unit or clinic in our facility. Prospective registry which will include all the HF patients evaluated in the Heart Failure unit or clinic. The patients will sign an informed consent form. After filling the informed consent the patients will be evaluated for clinical history and physical examination by the nurse and a cardiologist. Then, the patients may perform the following test: ECG, Chest X-RAY, Blood test including: complete blood count, renal and liver function, electrolytes, thyroid function, cholesterol, glucose, Troponin and Brain Natriuretic Peptide. It is impotent to mentions that all of the test mentioned above are being performed as part as the Heart Failure unit treatment and none are being done for the purpose of the study. After completing the evaluation the patients will be treated as needed by IV medications such as Furosemide, Iron, Dobutamine and Packed Cells. The data collected will include demographic: gender, age, hospitalization, diagnosis, symptoms, clinical as well as laboratory, echocardiographic and echocardiogram findings.

Identified details will be separated in a way that will not enable to review them. All data handling and the separation of the identified data will be done by the Principal Investigator, or sub-investigator in this study, who is in charge of the hearing screening program in our institution.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old
  • Patient evaluated in the Heart Failure unit or clinic in our facility.
  • Approved consent.

Exclusion criteria

  • Patients who haven't signed the informed consent in the prospective group.

Treatment and study plan

registry-no intervention

Other

registry-no intervention After filling the informed consent the patients will be evaluated for clinical history and physical examination by the nurse and a cardiologist. Then, the patients may perform the following test: ECG, Chest X-RAY, Blood test including: complete blood count, renal and liver function, electrolytes, thyroid function, cholesterol, glucose, Troponin and Brain Natriuretic Peptide

Primary outcomes

  1. NP/ pro-BNP from baseline

    Time frame: 10 years

  2. QT measurements

    Time frame: 10 years

    ECG will be performed at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Laufer Perl, MD

CONTACT

[email protected]

972527360430

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2030
Study completion
2031
First posted
May 5, 2017
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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